B Braun Medical recalled 168,816 IV Administration Sets on October 29, 2025. The sets may allow backflow of medication from secondary containers into primary containers. This recall affects products sold worldwide, including the US, Canada, Germany, Guatemala, and Singapore.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact B Braun Medical Inc or your healthcare provider for instructions. Notification method: Letter
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The recall includes two models: Catalog Number 490385 (IV ADMIN SET, 10 DROPS/ML, 144 IN) and Catalog Number 490401 (IV ADMIN SET, 3 CARESITES, 120 IN). These products were distributed globally.
The IV Administration Sets have a potential for backflow of medication from secondary IV containers into primary containers. This risk can lead to incorrect dosages and treatment complications.
No specific incidents have been reported, but the hazard level is classified as high due to the serious implications of medication backflow.
Stop using the IV Administration Set immediately. Follow the recall instructions provided by B Braun Medical Inc and contact your healthcare provider for further guidance.
For more information, contact B Braun Medical Inc. Visit their website or call for further details regarding the recall.
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